Pharmaceutical Validation Engineer

Job Description

The Pharmaceutical Validation Engineer will be responsible for supporting the function and responsibilities of our client’s Pharmaceutical Manufacturing Technical Services/Product Research and Development department in collaboration with other organizational departments.

Responsibilities:

• Support the troubleshooting of operations and processing issues by performing lab-scale processing and/or data analysis review.
• Support developing new and optimizing current product for both internal and external production.
• Lead the development, implementation and closure of Change Controls, Deviation investigations and Corrective Actions/Preventative Actions (CAPA) within a timely manner.
• Generate and execute Installation/Operational/Process Qualification/Process Validation (IQ, OQ, PQ, PV) protocols and related summary reports.
• Support the Validation Master Plan and Calibration program activities in accordance with current USDA and FDA cGMPs.
• Collaborate with others to identify areas of improvements and facilitate the revision and approval of Standard Operation Procedures (SOP), Manufacturing Instructions (MI) and other documents.
• Perform risk assessments and support implementation of identified improvements.

Requirements:

• Bachelor’s degree in a Science related field with a minimum of 6 years’ experience in an USDA and/or FDA regulated industry, preferred.
• Masters and/or PhD degree in sciences is preferred
• Minimum of 3 years of qualification/validation experience.
• Knowledge of US FDA 21 CFR Part 117 and Q7 cGMP requirements.
• Self-motivated with a results driven approach and have the ability to manage multiple projects/tasks simultaneously.
• Strong written and verbal communication skills, including the ability to organize information and present it to peers and members of Senior Management.
• Proficient in Windows applications (Word, Excel, PowerPoint, Outlook, etc.) and other basic computer skills.